In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the  FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Among other requirements, covered facilities are required to provide a Unique Facility Identifier (“UFI”) recognized as acceptable by the FDA. This requirement applies both new facilities registering for the first time, and facilities renewing their registration. The UFI is used by the FDA to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. The UFI should be input in the UFI field in Section 2 of FDA Form 3537.

In August of 2018, the FDA issued guidance recognizing the Data Universal Numbering System (“DUNS”) number as an acceptable UFI. The DUNS number is administered by Dun & Bradstreet (“D&B”), a private data analytics and business intelligence service provider. DUNS numbers can be obtained by visiting the portal on D&B’s website.

This requirement began during the latest biennial registration renewal period, which ended on December 31, 2020. However, the FDA had allowed facilities more time to obtain and submit a UFI with their registration submission.

FDA Extends Flexibility Through December 2022

The FDA announced in March 2021 that it is further extending the time period to obtain and submit a UFI until December 31, 2022. The FDA stated that it does not intend to enforce the UFI verification requirements for the remainder of the 2020 biennial registration renewal cycle. The guidance provides information on how registrants may obtain and provide a UFI even if they were unable to obtain a UFI before December 31, 2020.

Interested parties have voiced concerns about obtaining a DUNS number in a timely manner. While the FDA expects all registrants to provide their DUNS numbers with their registration or renewal, the FDA has recognized that there may be a delay in obtaining a DUNS number. Accordingly, the FDA is allowing registrants who anticipate that they will be temporarily unable to provide a DUNS number an alternative recourse. To address stakeholder concerns with obtaining a DUNS number in a timely manner, FDA intends to allow registrants who anticipate that they will be temporarily unable to provide a DUNS number with their registration or renewal to enter “PENDING” in the UFI field of their registration. This temporary entry will allow for registrations and renewals to be submitted even if the registrant has not yet provided a DUNS number. Upon submission, registrants will have until December 31, 2022 to update their registration with their DUNS number.

Contact Us

Failure to update the registration with a valid DUNS number by the end of the next biennial registrational renewal cycle will result in cancellation of the registration for failure to renew. Diaz Trade Law has significant experience in FDA-related matters. If you require assisting obtaining a DUNS number, or if you require assistance renewing or submitting your registration as a first-time filer, contact us today at  info@diaztradelaw.com or 305-456-3830.

Escrito en Coautoría de Sharath Patil

Antecedentes del Registro de Instalaciones Alimentarias

La Ley Federal de Alimentos, Medicamentos y Cosméticos (“FD&C”) requiere que las instalaciones nacionales y extranjeras que fabrican, procesan, envasan o almacenan alimentos para consumo humano o animal en los Estados Unidos se registren con la Administración de Alimentos y Medicamentos de los Estados Unidos (“FDA ”).  La Ley de  Modernización de la Seguridad Alimentaria (“FSMA”) de la FDA modificó los requisitos de registro de instalaciones de alimentos en FD&C para exigir que las instalaciones nacionales y extranjeras presenten cierta información  adicional a la FDA y que renueven sus registros cada dos años durante el período que comienza el 1ero de Octubre y termina el 31 de Diciembre de cada año par.

Entre otros requisitos, las instalaciones deben proporcionar un identificador único de instalación (“UFI”) aceptado por la FDA. Este requisito se aplica tanto a las nuevas instalaciones que se registran por primera vez como a las instalaciones que renuevan su registro. La UFI es utilizada por la FDA para verificar que la dirección específica de la instalación asociada con la UFI es la misma dirección asociada con el registro de la instalación. El UFI debe ingresarse en el campo UFI en la Sección 2 del Formulario 3537 de la FDA.

En Agosto del 2018, la FDA emitió una guía que reconoce el número del Sistema de numeración universal de datos (“DUNS”) como un UFI aceptable. El número DUNS es administrado por Dun & Bradstreet (“D & B”), un proveedor de servicios de inteligencia empresarial y análisis de datos privados. Los números DUNS se pueden obtener visitando el portal en el sitio web de D & B.

Este requisito comenzó durante el último período de renovación del registro bienal, que finalizó el 31 de Diciembre del 2020. Sin embargo, la FDA le había otorgado a las instalaciones más tiempo para obtener y enviar un UFI con su presentación de registro.

La FDA Extiende la Flexibilidad Hasta Diciembre del 2022

En marzo del 2021, la FDA anunció que está ampliando hasta el 31 de Diciembre del 2022 el período de tiempo para obtener y enviar un UFI. La FDA declaró que no tiene la intención de hacer cumplir los requisitos de verificación de UFI durante el resto del ciclo de renovación de registro bienal del 2020 . La guía proporciona información sobre cómo los registrantes pueden obtener y proporcionar una UFI incluso si no pudieron obtener una UFI antes del 31 de Diciembre del 2020.

Las partes interesadas han expresado su preocupación por obtener un número DUNS de manera oportuna. Si bien la FDA espera que todos los solicitantes de registro proporcionen sus números DUNS con su registro o renovación, la FDA ha reconocido que puede haber una demora en la obtención de un número DUNS.

En consecuencia, la FDA está ofreciendo un recurso alternativo a los solicitantes del registro que anticipan que temporalmente no podrán proporcionar un número DUNS . Para abordar las inquietudes de las partes interesadas sobre la obtención de un número DUNS de manera oportuna, la FDA tiene la intención de permitir a los solicitantes de registro que anticipen que no podrán proporcionar temporalmente Número DUNS con su registro o renovación y puedan ingresar “PENDIENTE” en el campo UFI de su registro. Esta entrada temporal permitirá que se presenten registros y renovaciones incluso si el registrante aún no ha proporcionado un número DUNS. Tras la presentación, los inscritos tendrán hasta el 31 de Diciembre del 2022 para actualizar su registro con su número DUNS.

Contáctenos

Si no actualiza el registro con un número DUNS válido al final del próximo ciclo de renovación del registro bienal, se le cancelará el registro por no renovarlo. Díaz Trade Law tiene una experiencia significativa en asuntos relacionados con la FDA. Si necesita ayuda para obtener un número DUNS, o si desea que lo asistamos a renovar o enviar su registro como contribuyente por primera vez, contáctenos hoy a través del siguiente correo electrónico info@diaztradelaw.com o a través del siguiente número telefónico 305-456-3830.

The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:

• Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
• Facilities are required to renew their registration every other year.
• FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the document.

Diaz Trade Consulting provides both registration and U.S. Agent services to food facilities. To register or find more information about registration, owners and operators of facilities should visit www.FDA-USA.com.

For More Information check out the Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (7th Edition)-Revised.

On January 23, 2018, we advised you that FDA has also launched the Voluntary Qualified Importer Program (VQIP), a voluntary fee-based program which offers expedited review and entry of human and animal food into the United States. Importers interested in participating in VQIP will be required to meet a number of eligibility requirements, which include ensuring the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program.

These programs are additional tools FDA is using to help ensure that foods imported into the United States are produced in accordance with the same safety standards required of food produced domestically. Governments, agencies, or organizations that are interested in becoming recognized accreditation bodies may apply using FDA’s web-based application and submitting an application fee.

To read the final rule, click here: FSMA Final Rule on Accredited Third-Party Certification. For more information about this announcement, VQIP or the Accredited Third-Party Certification Program please contact info@diaztradelaw.com.

FDA originally extended the compliance deadlines for many of the FSMA provisions. However, on January 4, 2018, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FSMA as they apply to certain entities or activities. FDA stated that it will use the enforcement discretion period to “consider the most effective and practical approaches to address issues that have been raised since the FSMA rules became final and provide long-term certainty for stakeholders.”

The enforcement discretion announced today pertains to the following 4 specific regulations:

1. Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food),
2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food),
3. Foreign Supplier Verification Programs rule (FSVP), and
4. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety).

Specifically, FDA will allow enforcement discretion for:

• Certain facilities conducting farm-related activities that are subject to the preventive controls requirements,
  • FDA intends to exercise enforcement discretion for certain facilities that conduct farm-related activities because some establishments that fall outside of the current definition of “farm” conduct activities that are typically conducted by farms. However, because they fall outside of the definition, they are subject to the preventive controls and CGMP requirements.
• Written assurances in the “Customer Provisions” in the PC Human Food, PC Animal Food, FSVP, and Produce Safety Rules provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health,
  • FDA intends to exercise enforcement discretion for the written assurances requirements because FDA has received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than was anticipated by FDA
• Importation of food contact substances under FSVP, and
  • FDA intends to exercise enforcement discretion for food contact substances under FSVP because the FDA has determined that certain characteristics related to the nature of food contact substances, FDA’s premarket review and oversight of food contact substances, and the regulatory framework for these substances, it is appropriate to exercise enforcement discretion with regards to the FSVP regulation.
• Certain manufacturing/processing activities for human food by-products for use as animal food.
  • Because FDA has identified some activities it does not consider to be further manufacturing/processing for the purpose of determining whether the human food facility is subject to just the limited holding and distribution CGMPs, or full range of PC and CGMP requirements, FDA intends to exercise enforcement discretion for the following activities:
    • Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight, bulk, or volume and/or
    • Mixing, centrifuging, and similar activities to combine ingredients or separate components (e.g., water and solids)
  • However, enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards, or when these activities introduce animal food hazards.

The best way to comply with, and keep up to date with FSMA updates, is to have an expert by your side. Diaz Trade Law specializes in compliance with the FDA and other regulatory government agencies. For information on FSMA, contact us at 305-456-3830 or via email at info@diaztradelaw.com.

The morning kicked off with a networking breakfast where experienced and novice industry members were able to engage in meaningful dialogue about overlapping issues they experience in their respective workplaces in dealing with the topic of FSMA. We heard comments from small to large business on their current implementation strategies in place to ensure they meet FSMA requirements by FDA’s compliance dates.

The seminar promptly began at 9:00 am with introductory remarks by our own President, Jennifer Diaz. We had all attendees introduce themselves and include why this seminar was important to attend. We were glad to hear from majority of attendees that their reason for participating was to further their education on FSMA. One attendee commented, “Excited to hear from FDA about FSVP requirements and what the broker’s role is in the process.”

Next Representatives of Miami Free Zone explained their role in international business solutions as it provides users and visitors with convenient international business resources including turnkey FTZ solutions for distribution; a wholesale marketplace; an international business center environment; and premium showroom, office, and warehouse spaces. As well as providing FTZ users with flexible control over their domestic and foreign inventory, duty elimination and deferment, and high security standards for their businesses and valuable merchandise.

The first speaker was Elena O. Asturias, is a licensed U.S. Customs Broker, and Certified Customs Specialist providing customs brokerage services for imports. Elena provided top tips for custom brokers as she has been involved in logistics for over fifteen years, and has experience handling a broad range of commodities. Some helpful tips from here presentation include:

• Make sure food facilities that must be registered with the FDA pursuant to the Bioterrorism act are registered to avoid delays upon entry into the U.S.
• A major issue causing FDA to detain food products are product labeling violations
• Ensure you use correct Affirmation of Compliance (AofC) Codes
  • When the entry is filed with FDA, use AofC codes to affirm the products meets specific import requirements.
  • Depending on the product type, many AofC’s are required, and must be submitted upon time of entry.
  • The AofC is a 3 letter indicator, then the qualifier which will vary in format. In some cases no qualifier is required.
    • Examples: PFR is the code used to designate a Manufacturer Food Facility Registration Number and it’s used with a 11 digit qualifier.
      • PFR 12345678901
      • FDA Affirmation of Compliance (AofC) Code Quick Reference
• FSVP – Unique facility identifier (UFI)
  • As of May 30th, you will need to add the UFI (Unique Facility Identifier) when you transmit the entry.
  • The AofC code being added is FSV, which will require the following:
    • DUNS number (as acceptable UFI)
    • Importer name & address
    • Email address
    • If the importer doesn’t have a DUNS number yet, you can transmit UNK “unknown” temporarily.
  • ENTRY DATA TRANSMISSION PROCESS:
  •  

• ITACS
  • ITACS – Import Trade Auxiliary Communications System
  • Importers are able to see the current FDA status (as long as they have the entry number), using the ITACS system (you have the ability to monitor your shipments without having to call your broker!).

Lundy Patrick followed Mrs. Asturias’ presentation and echoed the significance of being familiar with the importation process. Mr. Patrick is Lieutenant Commander serves as a U.S. Public Health Officer assigned to the Florida District Office of the FDA as an Imports Compliance Officer.  There were questions and answers during his presentation as the attendees had submitted questions prior to the seminar.  Here are highlights from the discussion:

• Articles are expected to be in compliance AT THE TIME OF ENTRY. Therefore, you need to exercise due diligence to make sure the products you intend to import are in compliance PRIOR to the importation of the goods.
• The following food imports require Prior Notice:
  • Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)
  • Food transshipped through the U.S. to another country
  • Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the list of exemptions
• If you fail to provide Prior Notice, the food shipment is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a “Prohibited Act” under the laws FDA administers.
• If a food product is assigned for examination/sampling, FDA will examine and will collect samples. Historically between 1-2% get examined/sampled.
• Lieutenant Commander Patrick echoed the importance of product label compliance and stressed FDA does not pre-approve labels for food products.
• He stated that the State of Florida, the third busiest district, has had over 8,000+ detention and 2200+ Refusals and provided the top reasons for food product detentions:
  • Labeling Issues:
    • Incorrect or missing statement of identity/name of the food
    • Failure to List potential allergens
    • Failure to declare ingredients
    • Failure to bear nutrition labeling or the nutrition label is in incorrect format.
  • Most common Import Alerts the FDA sees in Florida:
    • IA 16-81 – “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella“
    • IA 99-05 – “Detention Without Physical Examination Of Raw Agricultural Products for Pesticides”
  • If Refused Goods are sold and Cannot be Redelivered for Export / Destruction, you may face:
    • Liquidated Damages and/or 19 USC 1592 Penalties

Thereafter, Giselle Jordan took the floor to discuss the hot topic of FSMA Compliance and Foreign Supplier Verification Program. Giselle is a Consumer Safety Officer at the Division of Import Operations of FDA. In August 2016, she joined the newly established Food Safety Verification Program Team. Here are highlights from her presentation:

• Resources:
  • www.fda.gov/fsma   ß SIGN UP (there is a subscription feature available)
• FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations.
  • The goal for FSMA is FOOD SAFETY
• Key Principles of FSVP Rule
  • Establishes explicit responsibility for importers to ensure the safety of imported food
  • Risk-based (according to types of hazards, importers, and suppliers)
  • Alignment with PC supply-chain provisions
  • Flexibility in meeting requirements (assessing activities conducted by others)

• Purpose of an FSVP
  • To provide adequate assurances that:
    • Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions
    • Food is not adulterated or misbranded (as it relates to allergen labeling)
  • Who Must Comply?
    • “Importer” is U.S. owner or consignee of a food at time of U.S. entry.
    • If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent to serve as the importer under FSVP (“FSVP Importer”).
    • Note that the responsibility for FSVP compliance lies with the FSVP Importer and the FSVP Importer can be different from the Importer of Record.
  • FSVP Exemptions
    • Firms subject to juice or seafood HACCP regulations
    • Food for research or evaluation
    • Food for personal consumption
    • Alcoholic beverages and alcoholic beverage ingredients (7%)
    • Food transshipped through U.S.
    • Food imported for processing and export
    • “U.S. foods returned”
    • Meat, poultry, and egg products subject to USDA regulation at time of importation
    • Low acid canned food facilities (microbiological hazards only)
  • Appropriate Verification Activities
    • Must document determination, performance, conduct, review and assessment of results
    • Verification activities include:
    • Onsite audits (qualified auditor), sampling and testing of the food, a review of foreign supplier relevant food safety records, other appropriate activities
  • To qualify as a “Very Small Importer”:
    • Must meet definition of a very small importer
    • Less than $1 million/yr. in human food sales
    • Less than $2.5 million/yr. in animal food sales
    • Annually documentation of eligibility
  • Compliance Dates
    • The final FSVP rule was published on November 27, 2015
    • First compliance date: May 30, 2017
    • Last compliance date: July 27, 2020
    • http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm

Jennifer Diaz concluded the seminar with best practices for due diligence and best practices for responding to enforcement actions and FDA Notice of Action. Check out DTL’s TOP 10 TIPS for importing food products into the U.S.

For more information on how we can help you through the maze of importing and FSVP email us at info@diaztradelaw.com.

A special thanks to all our prize winner for participating during the seminar. We appreciate your involvement and interest! For pictures of the event LIKE us on Facebook.

Subscribe Today to keep up with the latest Customs and International Trade Law News.

Our next Live Broadcast webinar will be held on Wednesday, May 24, 2017 to discuss Intellectual Property Rights Violations and the U.S. Customs & Border Protections Enforcement. More information is available here.

DTL will also be at the NEI will be hosting the 3rd annual Global Trade Educational Conference held on August 7-8. NEI is bringing customs brokers, freight forwarders, NVOCCs, OTI, service providers, importers, exporters and all global logistics professionals an opportunity to update themselves on industry developments and connect with colleagues old and new. To RSVP – Read more. . .

*****This document is provided for informational purposes only and does not constitute legal advice nor does use of this constitute the formation of an attorney-client relationship.******

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? 

1. For a limited time, registration is FREE!
2. You have the ability to hear DIRECTLY from FDA.
3. We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

Event Information: 

FSMA AGENDA

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

In the first seminar, attendees will learn the ABC’s of Antidumping & Countervailing Duties (AD/CVD) compliance and CBP Enforcement.

In the second seminar, FDA will focus on food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? 

1. For a limited time, registration is FREE!
2. You have the ability to hear DIRECTLY from CBP and FDA.
3. We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to the Centers of Excellence and Expertise (CEE) and Antidumping & Countervailing Duties (AD/CVD) for CBP, and food importation/FSMA related questions for the FDA. Please email your questions today to info@diaztradelaw.com!

Full details including registration information for BOTH seminars are below. 

May 10, 2017 ( 9 – 11 a.m.)

• ABC’s of AD/CVD & CBP Enforcement
• CLICK HERE for our draft agenda
  • Hear directly from CBP Import Specialists & an industry legal expert
  • TOP Tips when Importing to Ensure Compliance with AD/CVD
  • Valuable opportunity to speak direct with Supervisory Import Specialist with U.S. Customs and Border Protection and legal experts to address any concerns relating to CBP’s role in administering and enforcing imports subject to AD/CVD
  • *** CBP WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE

May 18, 2017 ( 9 – 1 2 p.m.)

• FDA FSMA Compliance Seminar for Importers
• CLICK HERE for our draft agenda
  • Hear directly from FDA & an industry legal expert
  • Overview of FDA requirements for importing food products
  • A discussion of best practices when working with your broker to expedite shipments (ACE, ITACS, PREDICT)
  • Overview of the FSMA, including an overview of the FSVP requirement (which has a compliance date of 5/30/17)
  • Best practices for due diligence and responding to enforcement actions and FDA Notices of Action
  • *** FDA WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE 

We look forward to seeing you at our World Trade Month events!

The Foreign Supplier Verification Program (FSVP) was created on November 27, 2015, as “a significant provision of the Food Safety Modernization Act (FSMA)”. The FSVP “shifts the burden of certifying the safety of food imports from [the] FDA to the importers themselves”. This means that importers must set up a program that verifies that both the foreign supplier of the food and the food itself will comply with United States (U.S.) laws.

What is Required of the Importer?

For the FSVP to be satisfied, an importer must:

• “Determine known or reasonably foreseeable hazards with each food;
• Evaluate the risks posed by a food, based on the hazard analysis, and the foreign supplier’s performance;
• Use the evaluation of the risk posed by an imported food and supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
• Conduct supplier verification activities;
• Conduct corrective actions.”

The first compliance date for importers subject to the FSVP rule is May 30, 2017.

Our previous blog: FSMA: STAY COMPLIANT WITH DTL’S ‘PICTURE’! goes into greater detail about what is required for an importer to be compliant for FSMA.

The Unique Facility Identifier:

For each line entry of food product offered for importation into the United States, the FSVP importer must provide its Unique Facility Identifier (UFI) recognized as acceptable by FDA. In addition, the final rule requires that for each line entry of food product offered for importation into the United States, the FSVP importer must also provide the importer’s name and electronic mail address.

The identification of importers is extremely important to the FDA and allows the FDA to “effectively implement, monitor compliance with, and enforce the FSVP requirements, which are designed to help ensure that imported foods meet U.S. safety standards”. As of March 31, 2017, the FDA now formally recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. Along with now being able to provide the DUNS number as a UFI, the importer must also provide “its legal business name, electronic mailing address, and UFI recognized as acceptable by the FDA for each line of food product offered for importation into the [U.S.]”.

What is the DUNS number?

Dun and Bradstreet assign “a unique nine-digit identifier for businesses.” This number sets up a business credit file, which is required by the U.S. Government “for contracts or grants”. The DUNS number is free for importers.

If you import food products, you must have a plan in place to comply with FDA’s FSMA, including FSMA! Diaz Trade Law would be pleased to assist you in complying with FDA, FSMA, and FSVP regulations and requirements. Contact us at info@diaztradelaw.com.

Each year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.   

* PC Human supply chain compliance deadline is 3/17/17 (general)/9/18/17 (small) or six months after supplier is required to comply with applicable rule. PC Animal supply chain compliance deadline is 9/18/17 (general)/9/17/18 (small) or six months after supplier is required to apply with applicable rule.

**Farms have additional two years to comply with certain water-related requirements. Separate compliance date for sprouts.

*** Very small importers and importers of food from very small suppliers are subject to modified requirements.

**** 3PAC provisions are effective as of the date of the final rule but cannot be implemented until the publication of the forthcoming Model Accreditation Standards.

These rules change the game, in a way that moves both compliance risk and enforcement potential to a whole new level, for the farms, ranches, facilities, logistics providers, and accreditation bodies that directly or indirectly comprise the US food industry.

The most crucial aspects of adapting to and managing this new reality entail (i) mastering the who, what, when, and where associated with the FSMA and (ii) developing and implementing the appropriate action(s). Based on our prior experience working with clients on FDA issues, the best advice we can provide entities coming within the scope of the FSMA is, as a matter of default operating orientation, to get the PICTURE:

“P” – Be Proactive – The FSMA shifts the compliance and enforcement paradigm from being reactive to being proactive. Don’t get caught flat-footed.

“I” – Stay Informed – The FSMA introduces new standards and practices and has lots of moving parts. There is already a lot of information out there, some of it good, some of it questionable. Identify and rely on trusted and experienced sources to help you navigate your company to a secure position.

“C” – Get Compliant – This is the heart of the FSMA. Write the plan and/or take the measures required for your company. If you find this confusing or overwhelming, retain the assistance of counsel with demonstrated FDA experience.

“T” – Train – The FSMA establishes extensive training opportunities. These are in addition to the wealth of educational resources and guidelines otherwise available on FDA websites. Use these to your advantage, in the spirit of reasonable care.

“U” – Use Good Judgment – The written compliance activities required of entities coming within the ambit of the FSMA can, to the extent they provide insight into company-specific procedures and practices, inadvertently create liability exposure. Be judicious in balancing compliance and confidential operating information. Always, as a hedge against undesired downstream FOIAs, characterize documents filed with the FDA as business proprietary. If you have doubts or questions in this regard, give us a call. We have the experience and knowledge to help.

“R” – Recordkeeping – It’s required. And knowing what’s required to keep could save you a lot of time and money down the road.

“E” – Embrace Technology – Whether video, GPS, water quality test kits, etc., there is an almost never-ending tide of technological applications that can be harnessed for the purpose of better ensuring your company’s compliance. It’s never been easier to work smart – and efficiently. Which goes a long way to avoiding costly issues with FDA.

In its fleshed out form, the FSMA is a far-reaching and complicated body of regulation whose standards and procedures should not be taken lightly. The dictates of prudent practice and reasonable care weigh in favor of retaining expert counsel. Let us know if you have any questions!

Updated on September 6, 2018.

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